Increasing HCV Linkage to Care Among People Who Inject Drugs

NCT04741750 | Completed

• 1 other identifier: GSHCV
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Our study will test the effectiveness of a simplified approach to delivering Hepatitis C Virus (HCV) care in a street-based mobile medical clinic among people who inject drugs in increasing treatment initiation, retention, and cure. Rates of HCV treatment initiation, retention, and cure will be compared between patients offered the simplified approach to delivering HCV care in a mobile medical clinic versus those who are linked to a community clinic delivering a current practice of usual care. The investigators hypothesize that the simplified approach to delivering HCV care in a street-based mobile medical clinic will result in higher treatment initiation, retention, and cure than the current practice of usual care in community clinics.

Conditions

Hepatitis C

Keywords

Hepatitis C; Hepatitis C treatment; People who inject drugs; Mobile medical clinic; People experiencing homelessness; Treatment initiation; Linkage to care; Quality improvement

Outcome Measures

Primary Outcomes (1)

• Number of patients who initiate HCV treatment

  Initiating treatment with a Direct-Acting Antiviral (DAA)

  6 months of follow-up

Secondary Outcomes (6)

• Number of patients who complete HCV treatment

  16 weeks after treatment initiation

• SVR12 rates

  At least 12 weeks following DAA completion

• Initiation rates for medication-assisted treatment (MAT) for Opioid Use Disorder

  During the first 3 months of follow-up after enrollment

• Persistent rate for MAT

  During 6 months of follow-up after enrollment

• Number of patients who receive abscess care

  During 6 months of follow-up after enrollment

Study Arms (2)

Usual Care within Community Clinics

NO INTERVENTION

Complete blood count, comprehensive metabolic panel, international normalized ratio, HCV RNA, hepatitis B virus (HBV) serologies, point of care HIV test, and point of care liver fibrosis measurement. HCV genotype if required by patient's insurance for prior authorization. Care for opioid use disorder and skin infection is offered. Completion of the initial visit workup is sufficient to initiate a prior authorization request for DAAs from payers and an appointment for MAT follow-up in a community clinic if indicated. Patient coordination; authorization with insurance companies; scheduling appointments, follow-up, and ancillary support services will be conducted by a Patient Navigator. Patients are seen every 2-4 weeks for monitoring and adherence support. HCV treatment regimens are at the discretion of the treating provider in accordance with AASLD/IDSA guidelines and insurance requirements. Twelve weeks after HCV therapy completion, SVR12 HCV RNA and SVR12 CMP tests will be obtained.

Simplified Care within a Mobile Medical Unit

EXPERIMENTAL

Simplified Care treatment is the same as for Usual Care with the exception that it is taking place within a mobile medical clinic that is scheduled to deliver treatment in alignment with regular syringe exchange services.

Other: Simplified HCV care within a mobile medical unit

Interventions

Simplified HCV care within a mobile medical unit OTHER

Delivers guideline-based care for HCV in a stream-lined manner on a mobile medical unit

Simplified Care within a Mobile Medical Unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Family Health Centers of San Diego: lead

Study Sites (1)

Family Health Centers of San Diego

San Diego, California, 92102, United States

Location

Related Publications (2)

• Ramers CB, Vawter N, Northrup A, Klaman SL, Lewis SV, Tam A, Del Aguila C, Lewis R, Mendez B, Reyes L, Matthews E, Rojas S, Godino JG. Simplified and Integrated Hepatitis C Virus Testing and Treatment Algorithm for Unhoused People Who Inject Drugs. Open Forum Infect Dis. 2025 May 22;12(6):ofaf302. doi: 10.1093/ofid/ofaf302. eCollection 2025 Jun.

  PMID: 40476033 DERIVED

• Klaman SL, Godino JG, Northrup A, Lewis SV, Tam A, Carrillo C, Lewis R, Matthews E, Mendez B, Reyes L, Rojas S, Ramers C. Does a simplified algorithm and integrated HCV care model improve linkage to care, retention, and cure among people who inject drugs? A pragmatic quality improvement randomized controlled trial protocol. BMC Infect Dis. 2024 Jan 19;24(1):105. doi: 10.1186/s12879-024-08982-1.

  PMID: 38238686 DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Allocation is concealed until intervention is assigned. The PI and those analyzing the outcome of the trial will remain blinded throughout the entirety of the study. Only the patients and those delivering the intervention will be aware of the allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pragmatic quality improvement randomized controlled trial will be conducted among 200 people who inject drugs (PWID) with chronic hepatitis C virus (HCV), age ≥18 years, recruited from Family Health Centers of San Diego's mobile clean syringe exchange program (CSEP). Patients will be recruited to undergo HCV testing. Patients with a positive HCV Ab rapid finger stick test will be randomly allocated (ratio 1:1) to receiving treatment immediately in a mobile medical clinic (n=100) or in a community clinic (n=100, this will serve as a concurrent control group).

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: February 5, 2021
• Study Start: February 2, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)